Kim Ki-Bong, Hwang Ho Young, Hahn Seokyung, Kim Jun Sung, Oh Se Jin
Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Korea.
Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, Korea.
J Thorac Cardiovasc Surg. 2014 Sep;148(3):901-7; discussion 907-8. doi: 10.1016/j.jtcvs.2014.03.057. Epub 2014 May 16.
The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial was designed to evaluate the noninferiority of the saphenous vein (SV) compared with the right internal thoracic artery ([R]ITA) used as a Y-composite graft.
A total of 224 patients who had undergone off-pump revascularization for multivessel coronary artery disease using the SV or RITA as a Y-composite graft based on the in situ left ITA were assigned randomly to the SV Y-composite graft (SV group, n = 112) or free RITA Y-composite graft (RITA group, n = 112). The primary endpoint was the 1-year angiographic patency rate of the second limb conduits (SV or RITA). Postoperative 1-year coronary angiograms were performed in 215 patients (SV group, 108; RITA group, 107).
The overall graft patency rate was 97.4% (745 of 765) at 1 year (97.9% in the SV group vs 96.9% in the RITA group, P = .362). The primary endpoint of the study, the 1-year patency rate of the SV composite grafts, was 97.1% (238 of 245) and was noninferior to that of the RITA composite grafts (97.1% [198 of 204]) with a 95% lower confidence limit of -2.6% (P < .001 for noninferiority). The graft qualities, evaluated using the FitzGibbon patency grades, were also similar between the 2 groups (P = .948). No statistically significant differences were found in the overall survival rates between the 2 groups at 1 and 4 years (P = .998). Also, no statistically significant differences were found between the 2 groups in the freedom from major adverse cardiac and cerebrovascular event rates at 1 and 4 years (P = .597).
The SV composite grafts were noninferior to the RITA composite grafts in terms of the 1-year angiographic patency rates.
隐静脉与右胸廓内动脉作为 Y 型复合移植物（SAVE RITA）试验旨在评估作为 Y 型复合移植物使用时，隐静脉（SV）相较于右胸廓内动脉（[R]ITA）的非劣效性。
共有 224 例因多支冠状动脉疾病接受非体外循环血管重建术的患者，根据原位左胸廓内动脉情况，使用 SV 或 RITA 作为 Y 型复合移植物，随机分为 SV Y 型复合移植物组（SV 组，n = 112）或游离 RITA Y 型复合移植物组（RITA 组，n = 112）。主要终点是第二支血管移植物（SV 或 RITA）的 1 年血管造影通畅率。215 例患者（SV 组 108 例；RITA 组 107 例）进行了术后 1 年冠状动脉造影。
1 年时总体移植物通畅率为 97.4%（765 支中的 745 支）（SV 组为 97.9%，RITA 组为 96.9%，P = 0.362）。该研究的主要终点，即 SV 复合移植物的 1 年通畅率为 97.1%（245 支中的 238 支），不劣于 RITA 复合移植物（97.1%[204 支中的 198 支]），95%置信下限为-2.6%（非劣效性 P < 0.001）。使用 FitzGibbon 通畅分级评估的移植物质量在两组间也相似（P = 0.948）。两组在 1 年和 4 年时的总生存率无统计学显著差异（P = 0.998）。此外，两组在 1 年和 4 年时无主要不良心脑血管事件发生率方面也无统计学显著差异（P = 0.597）。
在 1 年血管造影通畅率方面，SV 复合移植物不劣于 RITA 复合移植物。
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